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Antimicrobial Agents and Chemotherapy logoLink to Antimicrobial Agents and Chemotherapy
. 2000 Apr;44(4):1114–1115. doi: 10.1128/aac.44.4.1114-1115.2000

New Antimicrobial Agents Approved by the U.S. Food and Drug Administration in 1999 and New Indications for Previously Approved Agents

PMCID: PMC89828  PMID: 10722527

Date of approval Trade name (form) Generic name(s) Manufacturer Indications or use
5 Jan 99 Lamisil (emulsion, cream) Terbinafine hydrochloride Novartis Pharmaceuticals Corp. Expansion of labeling to include patients with onychomycosis of fingernail or toenail even when associated with nondermatophytes
5 Jan 99 Mepron (suspension) Atovaquone Glaxo Wellcome Inc. For prevention of Pneumocystis carinii pneumonia
22 Jan 99 Prevpac (tablet) Amoxicillin, clarithromycin, lansoprazole Tap Holdings Inc. For eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence
9 Mar 99 Lamisil (emulsion, cream) Terbinafine hydrochloride Novartis Pharmaceuticals Corp. For over-the-counter treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum
30 Mar 99 Sporanox (injectable) Itraconazole Janssen Research, Johnson and Johnson For treatment of blastomycosis, histoplasmosis and aspergillosis in immunocompromised and nonimmunocompromised patients
15 Apr 99 Agenerase (capsule) Amprenavir Glaxo Wellcome Inc. For use in children age 4 and older and in adults in combination with other antiretrovirals for HIV infection
26 May 99 Norvir (capsule, solution) Ritonavir Abbott Laboratories For treatment of HIV infection in combination with other antiretroviral agents
29 Jun 99 Norvir (capsule, soft gelatin) Ritonavir Abbott Laboratories For treatment of HIV infection in combination with other antiretroviral agents
30 Jun 99 Monistat dual pak (suppository) Miconazole nitrate Advanced Care Products Treatment of vulvovaginal candidiasis
1 Jul 99 Videx (tablets, powder for oral solution) Didanosine Bristol-Myers Squibb Co. Expansion of the monotherapy indication to provide for use in combination with other antiretroviral agents for treatment of HIV-1 infection
1 Jul 99 Zerit (capsules, oral solution) Stavudine Bristol-Myers Squibb Co. Expansion of the monotherapy indication to provide for use in combination with other antiretroviral agents for treatment of HIV-1 infection
14 Jul 99 Omnicef (powder for oral suspension) Cefdinir Parke Davis, Warner-Lambert Co. For a 5-day dosing regiment (7 mg/kg twice daily) for treatment of acute otitis media
26 Jul 99 Relenza (inhalant) Zanamivir Glaxo Wellcome Inc. For treatment of uncomplicated acute illness due to influenza virus in adults and adolescents 12 years and older who have been symptomatic for no more than 2 days
26 Jul 99 Lamisil (gel) Terbinafine Novartis Pharmaceuticals Corp. For treatment of tinea cruris
13 Aug 99 Cleocin (suppository) Clindamycin phosphate Pharmacia and Upjohn Co. For treatment of bacterial vaginosis
24 Aug 99 Ceftin (tablet) Cefuroxime axetil Glaxo Wellcome Inc. For treatment of acute bacterial maxillary sinusitis in pediatric patents
21 Sep 99 Synercid (injectable) Dalfopristin, quinupristin Rhone Poulenc Rorer Pharmaceuticals Inc. For treatment of complicated skin and skin structure infections and for treatment of vancomycin-resistant Entrococcus faecium
27 Oct 99 Tamiflu (capsule) Oseltamivir phosphate Hoffmann-La Roche Inc. For treatment of uncomplicated acute illness due to influenza infections in adults who have been symptomatic for no more than 2 days
28 Oct 99 Videx (tablet, powder for oral solution) Didanosine Bristol-Myers Squibb Co. For a new strength as well as allowing a change in dosing interval to once-daily administration in combination therapy for treatment of HIV-1 infection
8 Nov 99 Omnicef (capsule) Cefdinir Parke Davis, Warner-Lambert Co. For a 5-day dosing regimen (300 mg twice daily) for treatment of acute exacerbations of chronic bronchitis
24 Nov 99 Viracept (tablet, powder) Nelfinavir mesylate Agouron Pharmaceuticals Inc. For a 1,250-mg twice-daily dosing regimen in combination with other antiretroviral therapies as an alternative to the standard dosing regimen of 750 mg three times daily in combination with other antiretrovirals for treatment of HIV infection
10 Dec 99 Avelox (tablet) Moxifloxacin hydrochloride Bayer Corporation For acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin structure infections
17 Dec 99 Tequin (tablet; injectable) Gatifloxacin Bristol-Myers Squibb For community-acquired pneumonia; acute bacterial exacerbation of chronic bronchitis; acute sinusitis; uncomplicated skin and skin structure infections; uncomplicated urinary tract infections; complicated urinary tract infections; pyelonephritis; uncomplicated urethral, pharyngeal, and rectal gonorrhea in males; and endocervical, pharyngeal, and rectal gonorrhea in females
17 Dec 99 Penlac (solution) Ciclopirox Hoechst Marion Roussel Inc. For topical treatment in immunocompetent patients with mild to moderate Trichophyton rubrum onychomycosis of fingernails and toenails without lunula involvement

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